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Completed

NCT Number: NCT02262039

Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System

The purpose of this study is to determine if the Airseal System will reduce post-operative pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Transplantation Center

New Haven, Connecticut, 06520, United States

About this study

Our hypothesis is that Airseal Insufflation System will provide reduced mean operative insufflation pressure and operative mean ETCO2, resulting in improved post-operative pain control and improved operative safety.

The Airseal System has demonstrated decreased variability in intra-abdominal pressure, less post-operative shoulder pain, lower mean ETCO2 and reduced narcotic pain administration. These metrics have been demonstrated in human subjects undergoing gynecologic, urologic and bariatric procedures. The established benefits in a human model provide a foundation for translating this technology to living kidney donors. The advantage lies in the ability to improve pain-related outcomes in this population, which translates into increased living donation; the single solution to reduce mortality for patients suffering from end-stage kidney disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any living donor who has been approved to donate a kidney is eligible to participate.

Exclusion criteria

  • none

Treatment and study plan

Valveless recirculating insufflation (VTI)

Device

10 mmHg target pressure

Conventional pressure

Device

15 mmHg target pressure

Primary outcomes

  1. Narcotic Use (mg)

    Time frame: Intra-Operative on day of surgery

    Total Morphine Equivalents - mean in mg

  2. Narcotic Use (mg)

    Time frame: Post-operative (until time of discharge, typically 2-4 days)

    Total Morphine Equivalents - mean in mg

  3. Narcotic Use (mg)

    Time frame: Operative and Post-operative (until time of discharge, typically 2-4 days)

    Total Morphine Equivalent - mean in mg

Secondary outcomes

  1. Subjective Pain Score

    Time frame: 1 hour post-op

    Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.

  2. Subjective Pain Score

    Time frame: 6 hours post-op

    Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.

  3. Subjective Pain Score

    Time frame: 12 hours post-op

    Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.

  4. Mean ETCO2

    Time frame: intraoperative

    mean End-tidal carbon dioxide concentration in the expired air

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • SurgiQuest, Inc.

Registry information

Official study title

Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System: A Randomized Control Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 10, 2014
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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